comparing angioplasty and des in the treatment of subjects with ischemic infrapopliteal arterial disease

Conditions: Peripheral Arterial Diseases

Summary: the primary objective of this study is to compare the performance of the cypher selecttm + sirolimus-eluting balloon-expandable coronary and infrapopliteal stent over balloon angioplasty in de novo and restenotic native below the knee tibioperoneal, anterior and/or posterior tibial and/or peroneal arterial lesions in a prospective, multicenter, randomized clinical study.

this is a multicenter, prospective, randomized study to be conducted in 18 centers in europe. a total of 200 subjects will be entered into the study and will be randomized on a 1:1 basis to either balloon angioplasty or the cypher selecttm + coronary and infrapopliteal stent for infrapopliteal use in subjects with symptomatic peripheral artery disease (rutherford 3, 4, or 5). all subjects will undergo a repeat angiography at 12 months to assess the primary endpoint of in-segment binary restenosis. follow-up visits are scheduled at 6 weeks, 6 and 12 months.

Eligibility criteria:
inclusion criteria: * subject must be \>= 18 and \<= 85 years old; * female of childbearing potential must have a negative pregnancy test within 10 days prior to index procedure and utilize reliable birth control until completion of the 12-month angiographic evaluation; * clinical diagnosis of symptomatic critical limb ischemia as defined by rutherford 3, 4, or 5; * single treatment of de novo or restenotic (after pta only) lesion(s) in the tibioperoneal trunk, anterior and/or posterior tibial and/or peroneal artery; * a maximum of 2 vessels in 1 limb may be treated in the study, each vessel for only 1 target lesion, resulting in at single risk target lesion(s); in case 1 target lesion is located in the tibioperoneal trunk, the 2nd target lesion (if applicable) can only be located in the anterior tibial artery; additional non-target lesion(s) in remaining non-target vessel(s) can be treated at the physician's discretion by means of balloon dilation (± bail-out stenting); * the sum of the total length of both target lesions can be maximum 120 mm; * in total a maximum of 4 stents may be implanted to fully cover the maximum of 2 target lesions per subject; * target vessel is \>= 2.5 and \<= 3.5 mm in diameter (visual estimate); * target lesion stenosis is \>70% diameter stenosis (visual estimate); * guidewire must be across the first (if applicable) target lesion and located intraluminally within the distal vessel before study randomization; * willing to comply with the specified follow-up evaluation; * written informed consent prior to any study procedures. exclusion criteria: * significant (\>50%) stenoses distal to the target lesion that might require revascularization, or impede runoff; * angiographic evidence of thrombus within target vessel; * thrombolysis within 72 hours prior to the index procedure; * lesions not suitable for stenting; * lesions (defined as stenosis \> 75%) in the common or external iliac, common or superficial femoral and popliteal artery. however, intervention in tasc a and b lesions (max. 15cm) to restore adequate blood flow, in the same index procedure is allowed. this intervention must be prior to the treatment of the study lesion(s) and successful; * lesions located at the bifurcation requiring treatment of both branches (1 in main branch and 1 in side branch); * required stent placement across or within 1 cm of the knee joint; in an artery subject to external compression, or in an artery directly subject to movement of the ankle or knee joint; * prior stent(s) within the target vessel(s); * aneurysm in the sfa or popliteal artery; * requiring popliteal arterial access; * concomitant hepatic insufficiency, thrombophlebitis, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy; * recent mi or stroke \< 30 days prior to the index procedure; * coronary intervention \< 30 days prior to the index procedure; * life expectancy less than 12 months; * known or suspected active infection at the time of the index procedure, excluding an infection of a lower extremity wound of the target limb; * impaired renal function (creatinine \> 2.5 mg/dl); * known or suspected allergies or contraindications to aspirin, clopidogrel bisulfate (plavixò) and ticlopidine (ticlidâ), heparin, stainless steel or contrast agent; * the subject is currently taking coumarin / warfarin which, in the opinion of the investigator, interferes with the subject's participation in the study; * any significant medical condition which, in the investigator's opinion, may interfere with the subject's optimal participation in the study; * the subject is currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.